Associate Director, Shift Quality Operations (Cell and Genetic Therapies)

Location: Boston, MA, United States; on-site five days per week, with up to 5% travel.

Salary: $153,900–$230,900 per year, plus annual bonus and equity eligibility.

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of therapies for patients.

What you will do

• Lead shift-based quality assurance oversight for aseptic cell therapy manufacturing, including formulation, filling, inspection, material flow, and line clearance.
• Ensure manufacturing compliance with cGMP, GDP, site procedures, aseptic processing standards, and contamination control requirements.
• Support batch disposition readiness through manufacturing documentation, event, and quality observation review.
• Lead or support deviation triage, investigations, root cause analysis, impact assessments, and CAPA development.
• Provide real-time quality decisions during atypical events and act as the primary representative for critical quality escalations.
• Lead, coach, and develop shift quality professionals while maintaining inspection readiness and effective cross-functional collaboration.

Requirements

• Bachelor’s degree in biology, microbiology, chemistry, pharmaceutical sciences, engineering, or a related discipline.
• 8+ years of relevant experience in manufacturing, quality assurance, and/or quality control within biotechnology or a regulated pharmaceutical environment.
• 5+ years of experience in aseptic manufacturing, sterile operations, or parenteral production.
• Strong knowledge of cGMP regulations, aseptic processing, Annex 1, FDA sterile manufacturing expectations, contamination control, batch record review, deviation/CAPA systems, and quality risk management.
• Experience with shop floor QA oversight, eQMS, MES, LIMS, data visualization, or advanced analytics; people leadership experience is strongly preferred.
• Ability to work on-site five days per week in Boston, MA and make compliance-based decisions in real time.

Culture & Benefits

• Continuous learning focused on AI, technology, automation, and biotechnology trends.
• Medical, dental, and vision benefits with paid time off and seasonal company shutdowns.
• Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
• Inclusive workplace with equal employment opportunity and reasonable accommodation support.